Urinary T Lymphocytes Predict Renal Flares in Patients With Inactive Anti-neutrophil Cytoplasmic Antibody (ANCA) Associated Glomerulonephritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Prediction of renal relapse after six months depending initial CD4+ count
研究概览
简要总结
Urinary CD4+ and CD8+ T lymphocytes may predict renal flares in patients with inactive ANCA-associated vasculitis and thus serve as early non-invasive biomarkers. Urine samples of patients with inactive renal ANCA-vasculitis will be analysed by flow cytometry and compared to clinical outcome after 6 months.
详细描述
Data of previous studies have shown that counts of urinary T lymphocyte subsets correlate with disease activity in several immunological renal diseases, e.g. ANCA-associated glomerulonephritis. Thus, study authors hypothesise that CD4+, respectively CD8+, T effector memory lymphocytes found in urine samples of patients with inactive ANCA-vasculitis predict subsequent renal flares. Therefore, quantification of these cellular subsets might reliably predict relapse of ANCA associated glomerulonephritis at an early stage. In a prospective experimental study urine of patients with ANCA-vasculitis and no renal involvement or patients in renal remission will be analysed by flow cytometry. After 6 months of observation, clinical outcome and potential renal relapse will be determined and correlated to initial T lymphocyte count.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed ANCA-associated vasculitis (clinical diagnosis of granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions AND positive test for proteinase 3-ANCA or myeloperoxidase-ANCA)
- •no currently active renal involvement (defined as BVAS = 0 with exception of hematuria or proteinuria as signs of renal scars)
- •written and informed consent
排除标准
- •urinary tract infection
- •active menstrual bleeding
- •active renal involvement
- •other active renal disease (e.g. diabetic nephropathy)
- •Initially, we defined treatment with rituximab as exclusion criteria. However, upon closer examination, we recognized that this exclusion criterion was overly restrictive and may have inadvertently excluded eligible participants who met our other inclusion criteria. As a result of this reassessment, we have revised our exclusion criteria to no longer exclude individuals solely on the basis of receiving rituximab treatment.
结局指标
主要结局
Prediction of renal relapse after six months depending initial CD4+ count
时间窗: 6 months
* relapse defined as Birmingham Vasculitis Activity Score (BVAS) \> 1 + at least one renal element or * intensified treatment regime (Prednisolon equivalent \> 20 mg/d or novel induction treatment with Rituximab or Cyclophosphamide)
次要结局
- Prediction of renal relapse after 12 months depending initial CD8+ count(12 months)
- Prediction of renal relapse after 12 months depending initial CD4+/CD8+ subsets(12 months)
- Prediction of renal relapse after six months depending initial CD4+/CD8+ subsets(6 months)
- Prediction of renal relapse after six months depending initial CD8+ count(6 months)
- Prediction of renal relapse after 12 months depending initial CD4+ count(12 months)
研究者
Philipp Enghard
PD Dr. med.
Charite University, Berlin, Germany